ViiV Healthcare, majorly owned by GSK with Pfizer and Shionogi as shareholders, announced that the European Commission (EC) has authorized Apretude, also known as cabotegravir long-acting (LA) injectable and tablets, for HIV prevention. This revolutionary treatment is now the only approved HIV prevention option in the European Union that offers an alternative to 365 daily […]
Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, […]
Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]
Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Dolutegravir Tablets for Oral Suspension, 5 mg. This approval will allow Lupin to market a generic equivalent of ViiV Healthcare’s Tivicay PD Tablets for Oral Suspension, 5 mg. The tablets […]
Cabenuva FDA approval : ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its long-acting regimen Cabenuva for the treatment of HIV-1 infection in adult patients. According to ViiV Healthcare, Cabenuva is being given as a co-pack with a couple of injectable medicines that include the company’s integrase strand transfer […]
Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options. According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications […]
Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]
In the latest pharma industry news, ViiV Healthcare has bagged Juluca FDA approval for the maintenance treatment of virologically suppressed HIV-1 infection.
ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received approval from the U.S. Food and Drug Administration (FDA) for its two-drug regimen, Juluca, for the maintenance treatment of adults with virologically suppressed human immunodeficiency virus type 1 (HIV-1). This groundbreaking treatment, composed of dolutegravir 50mg and rilpivirine 25mg, is the first […]